Debarred Entity definition

Debarred Entity means a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity.

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Debarred Entity has the meaning set forth in Section 7.2.4.

Debarred Entity shall have the meaning set forth in Section 9.14.

Examples of Debarred Entity in a sentence

Each Party further covenants that if, during the Term, it becomes a Debarred Entity, Excluded Entity, or Convicted Entity or if any employee or agent performing any of its obligations hereunder becomes a Debarred Individual, Excluded Individual, or a Convicted Individual, or added to FDA’s Disqualified/Restricted List for clinical investigators, then such Party shall immediately notify the other Party.
Neither Party has ever been, is not currently, nor is it the subject of a proceeding that could lead to it becoming a Debarred Entity, Excluded Entity, or Convicted Entity and it will not use in any capacity, in connection with the obligations to be performed under this Agreement, any person who is a Debarred Individual, Excluded Individual or a Convicted Individual, nor are they listed on the FDA’s Disqualified/Restricted List for clinical investigators.

More Definitions of Debarred Entity

Debarred Entity has the meaning set forth in Section 11.3(b).

Debarred Entity has the meaning set forth in Section 5.1(h)(ii).

Debarred Entity has the meaning given in Article 9.2(c).

Debarred Entity means a corporation, partnership or association that is or has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.

Debarred Entity means an individual or firm that has been declared ineligible in accordance with the World Bank sanctions procedures to be awarded a World Bank financed contract for the periods indicated at: http://web.worldbank.org/external/default/main?theSitePK=84266&content MDK=64069844&menuPK=116730&pagePK=64148989&piPK=64148984;

Debarred Entity is a Person (other than an individual) that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b), or by another Regulatory Agency pursuant to a comparable statute, from submitting or assisting in the submission of any application for any [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. abbreviated or other drug application or generation or preparation of any data with respect thereto, or any affiliate of such Person.

Debarred Entity shall have the meaning set forth in Subsection 8.1(i) hereof.